Associate Director, Quality Assurance, Vendor Management

Astellas Pharma; Greater London; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

An established industry player is seeking an Associate Director for Quality Assurance in Vendor Management. This pivotal role involves overseeing the QA vendor oversight program, ensuring compliance with GxP regulations, and enhancing vendor performance. You will collaborate with global stakeholders to align QA strategies and manage vendor audits throughout the product lifecycle. With a hybrid working model, this permanent position offers the flexibility of home and office work, making it an attractive opportunity for experienced professionals in the pharmaceutical sector.

Qualifications

• Extensive experience in the pharmaceutical or biotech industry with strong regulatory knowledge.
• Proven expertise in GxP standards and quality management systems.

Responsibilities

• Develop and implement QA vendor audit and management strategies.
• Conduct vendor audits and maintain vendor compliance records.

Skills

GxP Regulations

Vendor Management

Risk-Based Methodologies

Quality Management Systems

Education

Bachelor’s Degree in a Relevant Field

Job description

Associate Director, Quality Assurance, Vendor Management

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Job Overview

In this role, you will manage and oversee Astellas’ Quality Assurance (QA) vendor oversight program, ensuring compliance with GxP regulations such as GMP, GCP, GVP, GLP, ERES, and CSV. You will define and execute QA vendor audit strategies, assess vendors through risk-based methodologies, and develop strategies to improve vendor performance and regulatory compliance.

Key Responsibilities

• Develop and implement QA vendor audit and management strategies.
• Conduct vendor audits and maintain vendor compliance records.
• Manage vendor risk mitigation and escalate issues as necessary.
• Collaborate with global stakeholders to align QA vendor management strategies.

Qualifications

• Extensive experience in the pharmaceutical or biotech industry with strong regulatory knowledge.
• Proven expertise in GxP standards and quality management systems.
• Experience in vendor audits and management throughout the product lifecycle.
• Bachelor’s degree in a relevant field or equivalent.

Additional Information

• Permanent, full-time position based in London, UK.
• Hybrid working model with flexibility for home and office work.